Technical Field
The present invention relates to a method for preparing granules or pills containing an extract of a plant, herbal medicine, or medicinal herb decoction in a high concentration, and granules or pills containing an extract of a plant, herbal medicine, or medicinal herb decoction in a high concentration, the granules or pills being prepared by the method.
Background Art
Various kinds of extracts, that is, a plant extract, a herbal medicine extract, and a medicinal herb decoction extract, exhibit effects of preventing and treating various diseases and various effects helpful to the human body, such as beauty treatment, immune enhancement, and health promotion. These various kinds of extracts have long been eaten, and have been recognized as medicines with high stability due to having lower toxicity than western medicines which are synthetic medicines, and thus have been variously researched and developed.
With this stream of times, the formulation of extracts has also been actively researched and developed. However, there is no effective solution to the problem in that the contents of effective ingredients in the formulated product of extracts are very low and thus a large dose needs to be taken. More specifically, the herbal medicine extract and the medicinal herb decoction extract are formulated into a liquid dosage form, a granule dosage form, or a pill dosage form, and a large dose of liquid, granule, or pill dosage form is taken at a single dose treatment, 2-4 times a day. Thus, a large amount of medicine needs to be carried and is in convenient to carry around, and a large dose of medicine needs to be frequently taken.
In addition, vegetable extracts, such as an herbal medicine extract and a medicinal herb decoction extract, are difficult to formulate into a dosage form that is easy to take since the content of hydrocarbons, including sugars, such as rhamnose, arabinose, galactose, glucose, xylose, uronic acid, mannose, and galacturonic acid, is very high at 45-65%. That is, the herbal medicine extract, when formulated into a powder, is difficult to handle due to severe moisture retention caused by sugars which are concentrated through the formulation into the powder, and is problematic in long-term storage as a solid dosage form for oral administration and in the maintenance of the stability of the dosage form, the content, and the like, due to a very high degree of moisture retention.
Extract powders, in particular, of Banhasihamtang, Hovenia dulcis, Allii Bulbus, Rehmanniae Radix, ginseng, and red ginseng concentrates, which have high contents of sugar and hydrocarbon, have a poor quality stability at room temperature due to moisture absorption thereof, and have a very low degree of fluidity due to the severe moisture absorption thereof, and thus are very difficult in formulation procedures or capsule filling procedures. In the case where other vehicles are added to overcome the problems above, the contents of active ingredients may be lowered more due to the addition of the additives. Thus, conventionally, various kinds of extracts need to be taken in a dosage form of a pill or powder in which the content of vehicle accounts for 60-80% and the content of actual extract is 20-40%.
Meanwhile, the formulation method of an extract according to the conventional art will be described as follows. The spray drying of the extract is a physical method for making a powder. According to the method, a powder product is produced by spraying a liquid sample as small droplets with a size of several tens to several hundreds of micrometers (10-200 μm) and drying the small droplets over high-temperature and hot air for a drying time of 5-30 seconds. This method is employed in 800 or more of pulverizing methods. However, the spray-dried powder has normal problems during the next treatment procedure or in the handling by a user, such as a lot of dust, poor fluidity, easy moisture absorption and oxidation, easy adherence, and poor re-solubility. A powder having high contents of sugar and hydrocarbon, particularly, has strong moisture absorption.
A fluidized-bed device sprays a liquid-phase material toward a top or bottom space from a nozzle, which is installed at the top or bottom of a fluidizing room, to generate particles having a similar shape to a dried product manufactured by spray-drying. At the same time, these particles are allowed to stay in a fluidized state inside the device for a predetermined period of time, so that adhering and coating of the particles by the liquid phase material are repeated, and thus the diameter of the particles becomes gradually increased.
With respect to the procedure for producing a product inside the fluidized-bed device, the liquid phase material is sent to the spray nozzle inside the fluidized room by a peristaltic pump, and then sprayed in a shape of a fog. The solution sprayed from the spray nozzle is dried in a droplet state, thereby generating primary particles. Thereafter, the primary particles adhere to each other by the spray liquid and then are dried, thereby generating particles which are shaped like a bunch of grapes, and the generated primary particles adhere to each other by the spray liquid, thereby growing into circular granules. The grown granule particles repeatedly pass through the vicinity of the spray nozzle, thereby slowly increasing the particle weight and diameter. When the particle diameter increases to some extent, the particles are highly likely to be in contact with the spray liquid material due to the weight of the particle itself, and the spray liquid makes the particles thicker since the surface area of the particles is small. Furthermore, the coating by surface tension for a short period of time before drying and then the drying are repeated, and thus the growth rate of the particles is faster. However, the fluidized-bed device can be normally operated only when certain content or more seeds (assembly) are allowed to stay in the device at the initial operation time to form a fluidized-bed. Various kinds of powders, such as starch, cellulose, and glucose, are used as base seeds (Korean Patent Publication No. 10-2009-0032096). However, on the other hand, these seeds function as an essential ingredient for reducing the content of active ingredient (e.g., extract) of the final product.
In this regard, Korean Patent Application Nos. 10-2007-0063355 and 10-2007-0141999 disclose a method for producing granules and pills using a fluidized-bed device adopting a lower spray manner without using base seeds. The method is characterized in that, when an extract concentrate is sprayed in the fluidized-bed device, the extract concentrate is dried by heat, to form a powder, and the dried powder is used as a seed. However, the power producing capacity and drying efficiency of the fluidized-bed device are very poor at 15-25% even though the fluidized-bed device also has a drying function of a spray drier.
Therefore, with respect to the method for producing granules of an extract using only the fluidized-bed device without base seeds, as described in the above prior patent documents, base seeds for forming an initial fluidized bed need to be primarily formed. However, the fluidized-bed device requires a lot of time due to the low capacity to form a powder, and thus the process efficiency is very low. Since the drying of droplets actually takes a long period of time due to the sugar and the content of sugar contained in a red ginseng concentrate, which is sprayed in the fluidizing room at a temperature 70-85° C., the surfaces of particles are sometimes in a wet state, and the liquid phase material may be coated to flow down on an inner wall of the fluidizing room. In the case where the internal temperature of the fluidizing room is increased to 100-150° C. to overcome the problem above, the drying capacity may be improved. However, the powder which is dried in a manner different from the spray drying is exposed to a high temperature for a long time, and thus may be carbonized. In this regard, Koran Patent Publication No. 10-2009-0032096 discloses a method for preparing spherical granules wherein seeds of 250-750 μm grown by spraying an extract onto various seeds of 200-750 μm and base seeds of 180-250 μm are used as mother granules, and finally spherical granules of 700-1500 μm containing 10-60% of seeds are produced.
Throughout this application, various patents and publications are referenced and citations are provided in parentheses. The disclosure of these patents and publications in their entities are hereby incorporated by references into this application in order to more fully describe this invention and the state of the art to which this invention pertains.